SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

•    Nutrition Warehouse Herbal Throat Lozenges

•    Holland & Barrett Herbal Throat Lozenges

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Lozenge contains:

200mg Slippery Elm Bark Powder (Ulmus rubra Muhl.)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Lozenge

Light brown oval biconvex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Traditional herbal medicinal product used to relieve sore throats associated with coughs and colds, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults, the elderly and children over 12 years:

One Lozenge to be sucked as required.

Children under 12 years of age:

The use in children and adolescents under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

Duration of use

Do not use for more than 7 days.

If the symptoms worsen during the use of the product or persist for more than 7 days, a doctor or qualified health care practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Do not use and consult your doctor if you have difficulty swallowing or breathing, if sore throat is severe and is accompanied by high temperature, headache, nausea or vomiting or if there is blood in the saliva.

The use in children and adolescents under 12 years of age is not recommended due to the lack of data on safety and efficacy.

Do not use for more than 7 days. If the symptoms worsen during the use of the product or persist for more than 7 days, a doctor or qualified health care practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7    Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8    Undesirable effects

None reported.

If any adverse reactions occur, a doctor or qualified health care practitioner should be consulted.

4.9 Overdose

No cases of overdose have not been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Xylitol

Calcium Phosphate Tribasic

Potato Starch Vegetable Fatty Acid Acacia

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5 Nature and contents of container

High density polyethylene tampertainer.

Pack size: 60 tablets.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Nutrition Warehouse Limited

Samuel Ryder House

Barling Way

Eliot Park

Nuneaton

Warwickshire

CV10 7RH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 14010/0031

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/03/2013

10    DATE OF REVISION OF THE TEXT

19/03/2013